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CompletedNCT06068946VENTUREUpdated Feb 12, 2025

VK2735 for Weight Management Phase 2

A Phase 2 interventional study of VK2735 and Placebo in Weight Loss, sponsored by Viking Therapeutics, Inc.. Completed at 20 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Viking Therapeutics, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Feb 2024, 2 years 7 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
176
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.

VK2735 or matched placebo will be administered once weekly.

02

Conditions studied

  • Weight Loss

Keywords

  • Overweight
  • Obese
03

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 176 is above the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

Viking Therapeutics, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18 years of age at the time of signing the informed consent
  2. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co-morbid condition (treated or untreated), and BMI \<50 kg/m2

Exclusion criteria

Exclusion Criteria:

  1. History of or current clinically significant medical or psychiatric disorder that, in the opinion of the Investigator, does not support study participation
  2. Self-reported body weight change of 5% or more within 3 months of screening
  3. Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)
  4. Current or past diagnosis of chronic pancreatitis
  5. Calcitonin ≥20 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
  6. Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening
  7. Any prescription or over-the-counter medications intended for weight loss within 6 months of screening
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
176 participants (actual)

Study arms

  • Placebo comparator
    VK2735 (Placebo)

    Placebo

    Biological: Placebo

  • Experimental
    VK2735 (Dose #1)

    VK2735 is a peptide GLP-1 and GIP dual agonist

    Biological: VK2735

  • Experimental
    VK2735 (Dose #2)

    VK2735 is a peptide GLP-1 and GIP dual agonist

    Biological: VK2735

  • Experimental
    VK2735 (Dose #3)

    VK2735 is a peptide GLP-1 and GIP dual agonist

    Biological: VK2735

  • Experimental
    VK2735 (Dose #4)

    VK2735 is a peptide GLP-1 and GIP dual agonist

    Biological: VK2735

Interventions

  • BiologicalVK2735

    VK2735 is a peptide GLP-1 and GIP dual agonist

  • BiologicalPlacebo

    Placebo comparator

06

What researchers measure

Primary outcomes

  1. Percent (relative) change from baseline to Week 13 in body weight

    To measure the efficacy of VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition

    Time frame: 13 weeks

Secondary outcomes

  1. Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13

    To measure the efficacy of VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition

    Time frame: 13 weeks

Other outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs), TESAEs, AESI

    To evaluate the safety and tolerability of VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition

    Time frame: 13 weeks

07

Study locations

20 sites
  • Viking Clinical Site #119
    Birmingham, Alabama 35235, United States
  • Viking Clinical Site #114
    Long Beach, California 90815, United States
  • Viking Clinical Site #110
    Los Angeles, California 90057, United States
  • Viking Clinical Site #113
    Tustin, California 92780, United States
  • Viking Clinical Site #116
    Clearwater, Florida 33756, United States
  • Viking Clinical Site #106
    Clearwater, Florida 33761, United States
  • Viking Clinical Site #112
    Jacksonville, Florida 32216, United States
  • Viking Clinical Site #105
    Ocoee, Florida 34761, United States
  • Viking Clinical Site #107
    Port Orange, Florida 32127, United States
  • Viking Clinical Site #104
    Indianapolis, Indiana 46260, United States
  • Viking Clinical Site #103
    Louisville, Kentucky 40213, United States
  • Viking Clinical Site #109
    Marrero, Louisiana 70072, United States
  • Viking Clinical Site #102
    Kansas City, Missouri 64131, United States
  • Viking Clinical Site #111
    Butte, Montana 59701, United States
  • Viking Clinical Site #108
    Knoxville, Tennessee 37920, United States
  • Viking Clinical Site #101
    Austin, Texas 78705, United States
  • Viking Clinical Site #118
    Austin, Texas 78731, United States
  • Viking Clinical Site #100
    Phoenix, Texas 85210, United States
  • Viking Clinical Site #115
    San Antonio, Texas 78229, United States
  • Viking Clinical Site #117
    San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06068946
Lead sponsor
Viking Therapeutics, Inc.
Responsible party
Sponsor
First posted
Oct 5, 2023
Start date
Aug 31, 2023
Primary completion
Feb 27, 2024
Completion
Apr 2, 2024
Last update
Feb 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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